Dexamphetamine Sustained Release Pharmacokinetics and Clinical Validation of Dried Blood Spots

Netherlands Cancer Institute (NKI) logo

Netherlands Cancer Institute (NKI)

Status and phase

Completed
Early Phase 1

Conditions

Cocaine Addiction

Treatments

Drug: Dexamphetamine

Study type

Interventional

Funder types

Other

Identifiers

NCT02768441
DAM001DFM

Details and patient eligibility

About

The pharmacokinetics of 10 to 12 individuals receiving 60 mg of sustained release dexamphetamine will be studied. These individuals have received this medication before in a previous trial where the pharmacodynamics were investigated. This trial will last 5 consecutive days during which blood samples will be drawn for pharmacokinetics analyses. Dried blood spots will also be collected for the clinical validation of the bioanalytical method wherein these are used.

Enrollment

12 patients

Sex

All

Ages

25+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Have completed at least 80% of the previous study (CATCH)
  • Be able and willing to participate in the study and assessments
  • Have provided written informed consent.

Exclusion criteria

  • Any intake of dexamphetamine 7 days or less before the start of the proposed study;
  • Contraindications for dexamphetamine
  • (desired) pregnancy or continued lactation
  • Insufficient command of the Dutch language
  • Current participation in another trial

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

12 participants in 1 patient group

Study group
Experimental group
Description:
Participants receiving Dexamphetamine 60 mg SR
Treatment:
Drug: Dexamphetamine

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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